FDA 510(k) Application Details - K040844

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K040844
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	LIFE SPINE, LLC. 11965 EAST 65TH ST. SUITE 4 INDIANAPOLIS, IN 46236 US Other 510(k) Applications for this Company
Contact	MICHAEL S BUTLER Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2004
Decision Date	07/23/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review